A new antifungal drug developed by SCTNEXIS Inc (NASDAQ:SCYX) for the treatment of the yeast infection vulvovaginal candidiasis (VVC) has shown signs of superiority to standard treatments in a Phase2b clinical trial.
The news sent shares 10.3% higher to US$1.82 in midday trade.
The Phase 2b study, known as DOVE, analyzed the effect of five different doses of SCY-078, which is taken orally, compared to fluconazole, the standard treatment for VVC.
The doses for the study, which enrolled 186 patients suffering from VVC, ranged from 600mg to 1800mg while the duration of the treatment was either one day or three. The lowest SCY-078 dose of 600mg, which was given as two doses of 300mg every 12 hours, showed the best clinical results.
After 10 days, 14 of 27 patients in the group taking 600mg of SCY-078 were cured of their yeast infections compared with 14 of 24 patients receiving fluconazole. Over longer periods, the results were even more favorable, with the rate of clinical cure in patients getting 600mg of SCY-078 jumping to 70% against the 50% cure rate of patients receiving fluconazole.
“The positive effect of oral SCY-078 seen in this study was achieved at greatly reduced doses and with improved tolerability compared to our previous VVC Phase 2a study,” said David Angulo, chief medical officer of Scynexis. “The DOVE study accomplished its primary goal of identifying a well-tolerated oral dose regimen of SCY-078 with high clinical cure and mycological eradication rates."
The company is looking forward to a meeting with the US Food and Drug Administration to discuss the end of its Phase 2 trial and the start of registration for its Phase 3 trial.
The favorable results from the DOVE study follow the release of pre-clinical data that suggests SCY-078 has no negative impact on fertility, embryonic development or fetal development. The drug also works against the Candida species of fungal infections.
Keeping a Buy rating on the stock and a $6 price target, Jason McCarthy, an analyst with Maxim Group, called the fresh data a “significant positive” for Scynexis that “should pave the way to Phase 3 studies later this year.”
Currently, fluconazole is the sole oral option to treat VVC, which cracks the door open for the introduction of more antifungal therapies.
"With limited oral treatment options available for patients with VVC, and no approved products in recurrent VVC, the results observed in this Phase 2b study reinforce SCY-078's potential to address the unmet needs in these patients," said Marco Taglietti, CEO of Scynexis.